Trials / Active Not Recruiting
Active Not RecruitingNCT04809363
A Study of CDPATH™ to Help Manage and Treat Crohn's Disease
A Phase 4 Study Evaluating Real-World Use of CDPATH™, a Crohn's Disease Risk Prediction Tool
- Status
- Active Not Recruiting
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 200 (estimated)
- Sponsor
- Takeda · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
CDPATH™ is a tool to help predict the potential for developing Crohn's disease related complications in certain adult participants within 3 years. The main aim of the study is to explore the use of CDPATH™ to describe a participant's risk profile and to have discussions with their doctor about the potential path of their Crohn's disease. The number of visits will be decided by the study clinic according to their standard practice.
Detailed description
The tool being tested in this study is called CDPATH™. CDPATH™ is being used to provide a graphical representation of an individual participant's risk of developing a CD-related complication within three years, leveraging known participant risk factors based on clinical, serologic and genetic variables to help people categorize risk who have CD. This study will gather data on the use of the tool in real-world settings to inform practical use of CDPATH™. The study will enroll approximately 200 patients. Participants and health care providers (HCPs) will be surveyed to understand their satisfaction with the CDPATH™ process and with their treatment choice. This multi-center trial will be conducted in the United States. The overall time to participate in this study is 36 months. Participants will make multiple visits to the HCP's clinic, and data will be collected approximately every six months up to 3 years, based on the timing of routine follow-up appointments for assessment.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | CDPATH™ | Crohn's disease risk prediction tool. |
| OTHER | Blood Draw | Three blood samples will be drawn. |
Timeline
- Start date
- 2021-06-25
- Primary completion
- 2026-07-20
- Completion
- 2026-09-12
- First posted
- 2021-03-22
- Last updated
- 2025-11-05
Locations
44 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT04809363. Inclusion in this directory is not an endorsement.